# Making it last: A randomized, controlled trial of a home care system to promote persistence in PrEP care

> **NIH NIH R01** · EMORY UNIVERSITY · 2021 · $1,140,971

## Abstract

PROJECT SUMMARY/ABSTRACT
HIV pre-exposure prophylaxis (PrEP) has been shown in efficacy and effectiveness trials to achieve high levels
of protection, with over 95% protection among those with measurable levels of medication that indicate
adherence. This provides a substantial public health opportunity, with the US Centers for Disease Control and
Prevention (CDC) estimating that approximately 1.2 million US adults are eligible for PrEP, including 492,000
MSM. PrEP prescriptions are growing exponentially, with over 79,000 prescriptions between 2012 and 2015 in
the US. Guidance issued by CDC and by WHO calls for quarterly follow-up visits for those on PrEP, to include
behavioral and laboratory assessments, and treatment or counseling as needed. Currently, those on PrEP
must have in-person visits with their medical provider for such services, a system that places a large burden on
both providers and patients. If PrEP were to be scaled up to cover eligible, high-risk MSM in the United States,
we estimate over 1.5 million yearly patient visits would be required, a substantial burden on clinics seeking to
bring PrEP to scale. A related problem with bringing PrEP to scale is that patients may not persist in PrEP care
over time. This is particularly concerning because those patients in demographics with highest risk for HIV
acquisition, young and Black MSM, have been observed to be more likely to not persist in PrEP care over time.
The proposed research seeks to make PrEP scale-up more feasible and to increase persistence in PrEP care,
by developing a home-based monitoring and support system that would alleviate the need for quarterly, in-
person provider visits. We propose to conduct a randomized, controlled trial to determine whether participants
(half Black, half aged 18-34) randomized to the home care PrEP system have higher levels of retention in
PrEP care relative to standard of care control participants, as determined by biomarker and self-report. The
trial will be conducted at sites in Atlanta, GA, Boston, MA, Jackson, MS, and St. Louis, MO. We will also
conduct a mixed-methods assessment of trial results, and assess the cost-effectiveness of the home care
system.

## Key facts

- **NIH application ID:** 10191050
- **Project number:** 5R01MH114692-05
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** KENNETH H MAYER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,140,971
- **Award type:** 5
- **Project period:** 2017-08-25 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10191050

## Citation

> US National Institutes of Health, RePORTER application 10191050, Making it last: A randomized, controlled trial of a home care system to promote persistence in PrEP care (5R01MH114692-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10191050. Licensed CC0.

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